The U.S. Food and Drug Administration (FDA) posted a medical device safety alert concerning custom procedural trays or kits containing 1% Lidocaine HCl Injection, USP, 10 mg/mL, Lot 25-090-DK.
The products were recalled because there was one confirmed customer report where visible particulate were found in the primary product container in the form of dark red/black particles. The particular matter may dislodge through the tissue and could possibly cause a pneumothorax or haemothorax.
For details, please refer to the FDA website
http://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-0980-2014&w=02262014&lang=eng
If you are in possession of the product, please contact your supplier for necessary actions.
Posted on 27 February 2014